BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA INTRANASAL SPLINT

    MDR report key: 923042 · Received October 4, 2007

    Report

    Report Number
    3005940491-2007-00002
    Event Type
    Injury
    Date Received
    October 4, 2007
    Date of Event
    September 10, 2007
    Report Date
    October 1, 2007
    Manufacturer
    EVERA MEDICAL, INC.
    Product Code
    LYA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL IMPLANT WAS DEPLOYED IN 2007. THE DOCTOR STATED THAT "HE COULD ALWAYS FEEL THE IMPLANT DISTALLY" PRIOR TO THE REMOVAL DATE. THE DOCTOR STATED THAT THERE WAS NO INFECTION. THERE WAS SWELLING AT THE POINT OF EXTRUSION. THE EXPLANTED DEVICE WAS DISCARDED AT THE DOCTOR'S FACILITY AND IS UNAVAILABLE FOR EVAL. THERE WERE NO DEVICE PERFORMANCE ISSUES ACCORDING TO THE DOCTOR . THE DEVICE HAD MAINTAINED VOLUME AS INTENDED. THE LOT NUMBER OF THE DEVICE WAS NOT ENTERED ON THE PT CHART AND REMAINS UNK. FURTHER DISCUSSION WITH THE DISTRIBUTOR INDICATE THAT THE DOCTOR USED A SINGLE INCISION TECHNIQUE WHICH CAN RESULT IN SUPERFICIAL PLACEMENT AT THE DISTAL END. THIS USER ERROR IS THE LIKELY EXPLANATION FOR THE EVENT.

    Description of Event or Problem · 1

    PT REPORTED AN EXTRUDING IMPLANT TO DOCTOR IN 2007, AND THE EVERA SALES REP WAS NOTIFIED ON THE FOLLOWING DAY. PT PRESENTED WITH AN EXTRUDED IMPLANT ON THE DISTAL END ON ONE DAY LATER. THE DEVICE WAS EXPLANTED AND A REPLACEMENT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVERA INTRANASAL SPLINT INTRANASAL SPLINT LYA EVERA MEDICAL, INC. NA NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention